(28 days)
Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.
Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.
Ez3D-i is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc..for the benefit of effective doctor and patient communication and precise treatment planning.
Ez3D-i is a useful tool for diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;
- · Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP
- · Versatile 3D image viewing via MPR Rotating, Curve mode
- · "Sculpt" for deleting unnecessary parts to view only the region of interest.
- Implant Simulation for efficient treatment planning and effective patient consultation
- · Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
- · "Bone Density" test to measure bone density around the site of an implant(s)
- · Various utilities such as Measurement, Annotation, Gallery, and Report
- · 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
- · Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density
The provided text is a 510(k) summary for the Ez3D-i / E3 dental imaging software. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed performance data, acceptance criteria, or study specifics requested in your prompt.
The document states:
- "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." (Page 5)
This statement indicates that performance testing was performed and passed, but it does not provide any specific acceptance criteria, reported device performance metrics, sample sizes, data provenance, ground truth establishment, or details about comparative effectiveness studies.
Therefore, I cannot fulfill your request for the specific acceptance criteria and study details based purely on the provided text. The document is a regulatory submission summary, not a detailed technical report of the validation study.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).